This invention is directed to delivery devices for delivering subcutaneous cavity marking devices. More particularly, the delivery device may be used with biopsy systems permitting efficient placement of a biopsy marker within a cavity. The device may include an intermediate member which assists in deployment of the marking device. The device may also include a deployment lock to prevent premature deployment of a biopsy marker. The invention may further include the capability to match an orientation of a biopsy probe that has been rotated upon procurement of a biopsy sample.
Over 1.1 million breast biopsies are performed each year in the United States alone. Of these, about 80% of the lesions excised during biopsy are found to be benign while about 20% of these lesions are malignant.
In the field of breast cancer, stereotactically guided and percutaneous biopsy procedures have increased in frequency as well as in accuracy as modem imaging techniques allow the physician to locate lesions with ever-increasing precision. However, for any given biopsy procedure, a subsequent examination of the biopsy site is very often desirable. There is an important need to determine the location, most notably the center, as well as the orientation and periphery of the subcutaneous cavity from which the lesion is removed.
In those cases where the lesion is found to be benign, for example, a follow-up examination of the biopsy site is often performed to ensure the absence of any suspect tissue and the proper healing of the cavity from which the tissue was removed. This is also the case where the lesion is found to be malignant and the physician is confident that all suspect tissue was removed and the tissue in the region of the perimeter of the cavity is xe2x80x9ccleanxe2x80x9d.
In some cases, however, the physician may be concerned that the initial biopsy failed to remove a sufficient amount of the lesion. Such a lesion is colloquially referred to as a xe2x80x9cdirty lesionxe2x80x9d or xe2x80x9chaving a dirty marginxe2x80x9d and requires follow-up observation of any suspect tissue growth in the surrounding marginal area of the initial biopsy site. Thus, a re-excision of the original biopsy site must often be performed. In such a case, the perimeter of the cavity must be identified since the cavity may contain cancerous cells. Moreover, the site of the re-excised procedure itself requires follow-up examination, providing further impetus for accurate identification of the location of the re-excised site. Therefore, a new marker may be placed after re-excision.
While biopsy markers are well known, examples of improved biopsy markers are described in U.S. Pat. Nos. 6,356,782 entitled xe2x80x9cSUBCUTANEOUS CAVITY MARKING DEVICE AND METHODxe2x80x9d and 6,371,904 entitled xe2x80x9cSUBCUTANEOUS CAVITY MARKING DEVICE AND METHODxe2x80x9d each of which is incorporated by reference herein. Placement of such biopsy markers may occur through either invasive surgical excision of the biopsy, or minimally invasive procedures such as fine needle aspiration or vacuum assisted biopsy.
In a fine needle aspiration biopsy, a small sample of cells is drawn by a thin needle from the lump or area of suspect tissue. If the suspect area or lump cannot be easily felt, non-invasive imaging may be used to help the doctor guide the needle into the right area. A core biopsy is similar to a fine needle aspiration biopsy, except that a larger needle is used. Under a local anaesthetic, the doctor makes a very small incision in the patient""s skin and removes several narrow sections of tissue from the suspect area of tissue through the same incision. The core biopsy provides a breast tissue sample rather than just individual cells. Thus making it easier for the pathologist to identify any abnormalities.
Vacuum-assisted biopsy is performed through the skin and may rely upon ultrasound or stereotactic guidance to determine the location of a suspect area of tissue. Two commonly used vacuum-assisted breast biopsy systems are Mammotome(copyright) supplied by Johnson and Johnson Ethicon Endo-surgery or MIBB(copyright) supplied by Tyco International. Examples of such devices may be found in U.S. Pat. No. 5,526,822 entitled xe2x80x9cMethods and Apparatus for Automated Biopsy and Collection of Soft Tissue,xe2x80x9d U.S. Pat. No. 5,649,547 entitled xe2x80x9cMethods and Devices for Automated Biopsy and Collection,xe2x80x9d U.S. Pat. No. 6,142,955 entitled xe2x80x9cBiopsy Apparatus and Methodxe2x80x9d and U.S. Pat. No. 6,019,733 entitled xe2x80x9cBiopsy Apparatus and Methodxe2x80x9d the entirety of each of which is incorporated by reference herein. Such breast biopsy systems include a probe that is inserted through the skin and is usually adapted to provide a vacuum to assist in obtaining the biopsy sample.
FIGS. 1A-1D illustrate an exemplary biopsy probe 10. As illustrated, the distal ends of probes 10 of these biopsy systems are adapted to both penetrate tissue and to contain a cutting member 12 which facilitates the removal of the biopsy sample. The cutting member 12 will contain an aperture 14 (often referred to as a xe2x80x9cprobe window.xe2x80x9d) The aperture 14 may be located on a side of a probe 10.
Once inserted through the skin, the cutting member 12 of the probe 10 aligns with suspect tissue 1 via stereotactic, ultrasound, or other means. After proper positioning of the probe 10, a vacuum draws the breast tissue 1 through the probe aperture 14 into the probe 10. As illustrated in FIG. 1B, once the tissue 1 is in the probe 10, the cutting member 12 actuates to capture a tissue sample 3. The tissue sample 3 may then be retrieved through the probe 10 to a tissue collection area (e.g., a standard pathology tissue cassette). FIG. 1C illustrates the probe 10 after the tissue sample is cleared from the aperture 14. Note that the illustration depicts a portion of the cutting member 12 as being retracted, leaving aperture 14 open; the cutting member 12 may alternatively be placed in a closed position during retrieval of the tissue sample.
The biopsy system is often adapted such that the cutting member 12 and aperture 14 rotate (e.g., via manipulation of a thumbwheel on the probe or biopsy system) with respect to the biopsy system. After excision of a tissue sample from the area of suspect tissue, the radiologist or surgeon may rotate the probe 10 and the aperture 14 to a new position relative to the biopsy system. FIG. 1D illustrates the probe 10 and aperture 14 after being rotated but without being removed from the body. The rotation of the probe 10 and aperture 14 permits excision of multiple subsequent biopsy samples from a target area of suspect tissue with only a single insertion of the biopsy probe 10. It should be noted that FIG. 1D is provided merely to illustrate the rotation of the probe 10 within the body. As such, the placement of biopsy markers is not illustrated in the figure. Moreover, the cutting member 12 is depicted in a closed position. This may ease rotation of the probe 10 within the tissue.
The entire cycle may be repeated until sampling of all desired areas occurs (typically, 8 to 30 samples of breast tissue are taken up to 360 degrees around the suspect area). Accordingly, it is important that the operator of the biopsy system is able to identify the orientation of the probe aperture 14 relative to the biopsy system at any given time while the probe aperture 14 remains within the tissue. Often, demarcations on the thumbwheel permit the identification of the probe orientation.
The above described removal of tissue samples creates tissue cavities. Hence, for reasons that are apparent to those familiar with such biopsy procedures, placement of a biopsy marker through the probe is most desirable. For example, repeated removal of the probe and insertion of a biopsy marking device may cause unneeded additional discomfort to the patient undergoing the procedure; removal of the probe may introduce error in placement of the biopsy marker into the desired location; repeated removal and insertion of each of the devices may prolong the duration of the procedure or spread cancer cells; after the probe removes a tissue sample, it is in the optimal location to deposit a marker; etc.
Biopsies may be performed with other tissue sampling devices as described in U.S. Pat. Nos. 4,699,154; 4,944,308, and 4,953,558 the entirety of each of which is incorporated by reference herein. Such devices obtain a biopsy sample through a hollow biopsy needle having an aperture located in a distal end of the biopsy needle. As with the biopsy devices previously described, once the tissue sampling devices removes tissue and creates a biopsy cavity, it may be desirable to place a marker in the area of the biopsy cavity.
In view of the above, there remains a need for an improved biopsy marker delivery system that may facilitate placement of a biopsy marker and also may be used with commercially available biopsy systems.
This invention relates to delivery systems for delivery of biopsy cavity marking devices. A basic variation of the invention includes a tissue marker delivery device comprising a tube having a lumen extending therethrough, a tissue marker removably seated in a distal end of the tube, a rod slidably located within the tube lumen and having a first end extending through a proximal end of tube and a second end in the tube lumen; and an intermediate member separating the rod from the biopsy marker, where advancement of the rod in a distal direction displaces the intermediate member to displace the tissue marker from said marker seat. In a variation of this invention, the intermediate member is discrete from both the rod and the tissue marker. The intermediate member may comprises a flexible covering as described herein.
Another variation of the invention includes a delivery device for use with a biopsy probe having an aperture, the delivery device comprising a body having proximal and distal ends and a passageway extending therethrough, an elongate sheath having a lumen extending therethrough, the sheath extending distally from the distal end of the body, the sheath lumen in fluid communication with the body passageway, an access tube having a proximal and a distal end and a lumen extending from at least a portion of the access tube through the proximal end, the access tube slidably located within the body passageway and the sheath lumen, a marker seat located towards the distal end of the access tube, a rod slidably located within the access tube lumen and having a first end extending through the proximal end of the body and a second end in communication with the marker seat, wherein advancement of the rod in a distal direction advances the marker seat distally until the marker seat is adjacent to the probe aperture such that a marker in the marker seat may be deployed from the aperture. For example, when using a biopsy probe having an aperture in a side wall of the probe, the marker seat may be advanced within the aperture and subsequently deploys a marker. When the inventive device is used with biopsy probes having an aperture in a distal end of the probe, the marker seat may be advanced just proximal to the aperture in preparation for subsequent deployment of the marker.
The rod may advance the marker seat through a number of configurations. For example, the rod may be sized to have an interference fit with a portion of the access tube lumen. Another example includes a device configured such that the rod engages a marker which is situated in the marker seat. In such a case, a sheath may restrain the marker in the marker seat. Thus, until the marker is no longer constrained by the sheath, the rod will advance the marker within the sheath. In another variation, the rod may be in communication with a fluid that is itself in communication with the marker seat. In such a case, the rod may apply a force on the fluid to advance the marker seat and/or displace a marker from the marker seat. In some variations, the fluid may serve to displace a flexible covering out of the marker seat. It is contemplated that the rod of the present invention may advance the marker seat through a combination of configurations either described herein or known to those familiar with similar delivery devices.
A variation of the invention also includes a delivery device as described above, wherein the body further comprises a keyway along the passageway, and the body has an orientation being defined relative to the keyway, the delivery device further comprising an access tube key located on the access tube and adapted to be slidably located within the body keyway, the access tube key adapted to maintain an orientation of the access tube with the body orientation.
Variations of the invention may also include a deployment lock having a first end and a second end, the first end moveably located in the body and the second end located outside of the body, the first end adapted to engage a portion of the rod to prevent at least distal movement of the rod, whereupon disengagement of the first end of the deployment lock from the portion of the rod permits distal movement of the rod. The deployment lock may be removable from the device or may be moveable within the device so as to permit disengagement of the lock from the rod while still being attached to the body of the device.
The invention also may include a rod stop fixedly located on the rod, wherein after the rod is advanced into the marker seat, the rod stop engages the access tube stop preventing further distal movement of the rod. The rod stop may also include a rod key that is adapted to maintain an orientation of the rod with the body orientation.
A variation of the device includes an access tube stop fixedly located on a portion of the access tube being located within the body, wherein advancement of the rod in a distal direction advances the marker seat distally until the access tube stop engages the distal end of the body preventing further distal movement of the access tube whereupon further distal advancement of the rod advances into the marker seat. In one variation of the invention, engagement of the access tube stop against the distal end of the body places the marker seat adjacent to the biopsy probe aperture.
In another variation of the invention a portion of the distal end of the access tube is removed to define the marker seat. The invention may also include a covering located over at least the marker seat, where at least a portion of the covering is adapted to displace into and out of the marker seat. Movement of the rod into the marker seat displaces the covering out of the marker seat. In variations of the invention using such a covering, there is no direct contact between the actuator (e.g., rod, etc.) and a marker placed within the marker seat.
In another variation of the invention, the inventive device includes a delivery device key adapted to seat in the biopsy probe and maintain an orientation of the access tube with an orientation of the biopsy probe. The delivery device key may be located on the elongated sheath or on the body of the device. In some variations of the invention, seating the delivery device key in the biopsy probe will cause a distal end of the outer sheath to be placed immediately proximal to the biopsy probe aperture.
Variations of the invention also may include a biopsy marker that is seated in the marker seat.
Although the delivery device and method described herein for delivering a marking device to a subcutaneous cavity is suited for use with a biopsy probe, the invention is not necessarily limited as such. Variations of the inventive device may be used with any type of biopsy procedure.
The invention also contains a kit containing a biopsy marker delivery device as described herein and an introducer cannula. The introducer cannula may be used to facilitate insertion of the delivery device into the patient to assist in delivery of a biopsy marker. The kit may also include a biopsy probe. The biopsy probe may be a spring-loaded biopsy probe.
The invention also includes a method for marking a biopsy cavity. In one variation, the inventive method includes using a delivery device having a marker, a tube removably seating the marker, a rod within the tube, and an intermediate member separating the rod and the marker, the method comprising, advancing the marker and delivery device to the biopsy cavity, actuating the rod to displace the intermediate member on the delivery device; and depositing the marker in the cavity upon displacing the intermediate member.